| Device Type ID | 5604 |
| Device Name | Tourniquet, Nonpneumatic |
| Regulation Description | Nonpneumatic Tourniquet. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.5900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GAX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5604 |
| Device | Tourniquet, Nonpneumatic |
| Product Code | GAX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpneumatic Tourniquet. |
| CFR Regulation Number | 878.5900 [🔎] |
| Device Problems | |
|---|---|
Decrease In Pressure | 2 |
Break | 2 |
Torn Material | 2 |
Device Operational Issue | 2 |
Device Dislodged Or Dislocated | 1 |
Device Markings / Labelling Problem | 1 |
Positioning Failure | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical, Inc. | II | Aug-20-2014 |
| 2 | Pyng Medical Corporation | II | Nov-05-2015 |
| 3 | The Seaberg Company Inc | II | Jun-14-2018 |